NURTEC ODT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RIMEGEPANT AS SULFATE

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

Pharmaceutical form:

ORALLY DISINTEGRATING TABLETS

Composition:

RIMEGEPANT AS SULFATE 75 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BIOHAVEN PHARMACEUTICALS INC., USA

Therapeutic indications:

NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: • acute treatment of migraine with or without aura in adults • preventive treatment of episodic migraine in adults

Authorization date:

2021-03-01

Patient Information leaflet

Nurtec PIL CC 05 Dec 2022 TC
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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
NURTEC
ODT
®
ORALLY DISINTEGRATING TABLETS
FOR ORAL OR SUBLINGUAL USE
ACTIVE INGREDIENT AND QUANTITY:
EACH ORALLY DISINTEGRATING TABLET CONTAINS:
RIMEGEPANT 75 MG (EQUIVALENT TO 85.65 MG RIMEGEPANT SULFATE)
For a list of inactive ingredients and allergens - see section 6
"Further information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Nurtec ODT, orally disintegrating tablets, are indicated for:
•
Acute treatment of migraine attacks with or without aura in adults.
•
Preventive treatment of episodic migraine.
THERAPEUTIC GROUP: Calcitonin gene-related peptide (CGRP) receptor
antagonist,
antimigraine medicine.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (rimegepant) or
to any of the other
ingredients in this medicine (see section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
ALLERGIC REACTIONS. Allergic reactions, including trouble breathing
and rash, can happen after you
take this medicine. This can happen days after you take the medicine.
If you experience an allergic
reaction, stop using it and begin appropriate treatment (see section 4
"Side effect").
BEFORE TREATMENT WITH NURTEC ODT, TELL YOUR DOCTOR IF:
•
You have liver problems.
•
You have kidney problems.
•
You are pregnant or plan to become pregnant.
•
You are breastfeeding or plan to breastfeed.
CHILDREN AND ADOLESCENTS
There is no information regarding the safety and effectiveness of this
medicine in children and
adolescents.

Summary of Product characteristics

Nurtec LPD CC 29 May 2023
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2023-0085070
_ _
PHYSICIAN PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Nurtec ODT
Orally disintegrating tablets
_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orally disintegrating tablet contains 75 mg rimegepant
(equivalent to 85.65 mg rimegepant sulfate).
For the full list of excipients,
_see Description (11)_
.
PHARMACEUTICAL FORM
Orally disintegrating tablets
_ _
1
THERAPEUTIC INDICATIONS
NURTEC ODT is a calcitonin gene-related peptide receptor antagonist
indicated for the:
•
Acute treatment of migraine with or without aura in adults
•
Preventive treatment of episodic migraine in adults_
_ _
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosing for Acute Treatment of Migraine
The recommended dose of NURTEC ODT is 75 mg taken orally, as needed.
The maximum dose in a 24-hour period is 75 mg. The safety of using
more than 18 doses in a 30-day period has
not been established.
2.2
Recommended Dosing for Preventive Treatment of Episodic Migraine
The recommended dosage of NURTEC ODT is 75 mg taken orally every other
day.
2.3
Administration Information
Instruct the patient on the following administration instructions:
•
Use dry hands when opening the blister pack.
•
Peel back the foil covering of one blister and gently remove the
orally disintegrating tablet (ODT).
Do not push the ODT through the foil.
•
As soon as the blister is opened, remove the ODT and place on the
tongue; alternatively, the ODT may
be placed under the tongue.
•
The ODT will disintegrate in saliva so that it can be swallowed
without additional liquid.
•
Take the ODT immediately after opening the blister pack. Do not store
the ODT outside the blister
pack for future use.
Nurtec LPD CC 29 May 2023
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2023-0085070
2.4
Concomitant Administration with Strong or Moderate CYP3A4 Inhibitors
Avoid concomitant administration of NURTEC ODT with strong inhibitors
of CYP3A4. Avoid another
dose of NURTEC ODT within 48 hours when it is concomitantly
administered with moderate inhibitors of
CYP3A4
_[see Drug In